FDA upgrades recall for tens of thousands of bottles of commonly prescribed medication

CINCINNATI (WKRC) – The FDA upgraded a recall for a commonly prescribed medication that may pose a health risk.

According to an updated enforcement report from the Food and Drug Administration, 54,532 bottles of levothyroxine sodium tablets were recalled because they were sub-potent, or not as strong as advertised. The recall was initially issued on September 16, but was upgraded to a Class II recall on October 8.

Class II recalls refer to “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA website.

The specific product recalled was “Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.”

The FDA issued a similar recall on July 14 for over 160,000 bottles of levothyroxine sodium tablets also manufactured by Intas Pharmaceuticals.

Levothyroxine sodium tablets are used to treat hypothyroidism, a disorder in which the thyroid does not produce enough hormones, according to the Epoch Times. The drug works as a form of hormone therapy, the outlet reported.